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Regulatory Affairs Manager

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Our client is a leading pharmaceutical organisation with activities ranging from product development, registration, production, and commercialisation of (bio)pharmaceutical products to providing pharmaceutical services. With over 200 professionals, the ambitions are expanding so that they can continue to provide their clients with the best services. In this expansion they are currently looking for a Regulatory Affairs Manager.




Geleen - Netherlands

40 hours per week

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QTC logo icon About your role

This is how you will make the difference

As Regulatory Affairs Manager you will be mainly compiling and managing registration dossiers for pharmaceutical products with the aim of obtaining registration in predefined markets, within established timelines and in consultation with the client. You will do this in close collaboration with the internal core team, starting from early formulation, process and analytical method development, during core team meetings. Also you will manage, plan, and coordinate variations in accordance with applicable guidelines and provide the Product Development team with regulatory strategy suggestions and concerns related to their formulation, process and analytical method development and validation strategies. For this you will effectively communicate with those directly involved in the licensing process (internally and externally) and competent regulatory authorities.

QTC logo icon what's needed

What you bring

Being the strong regulatory professional, you will recognise yourself in the following:

  • Minimum of 5 years of experience performing various regulatory affairs duties within a pharmaceutical company;
  • Thorough knowledge of EU and national regulations/guidelines in the field of regulatory affairs;
  • Solid understanding of compiling, updating, and amending registration dossiers, as well as electronic submission processes;
  • Proficiency in Word, Excel, and (preferably) Adobe Acrobat;
  • Familiarity with Medical Devices and Drug Device Combinations is a plus;
  • Detail-oriented, with strong planning, organizational skills, and results-driven mindset.

QTC logo icon What we offer

What's in it for you

On offer is a challenging and responsible position within a dynamic and growing organisation. You will receive a competitive salary and benefits package (including flexible working hours, hybrid work options, 28 vacation days, pension). Additionally there will be opportunities for professional development and growth in an inspiring and collegial work environment with an international character.

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